Renate Maria Hammerstingl MD, Presenter: Nothing to Disclose

Bernd Tombach MD, Abstract Co-Author: Nothing to Disclose

The purpose of this multicenter study was to evaluate the diagnostic efficacy of 1.0 M Gadobutrol versus 0.5 M Gd-DTPA in patients with known or suspected liver tumors.

This clinical trial was conducted as a phase-III multicenter, randomized, interindividually controlled comparison study with blinded reader evaluation. The primary goal was to evaluated the diagnostic efficacy in terms of accuracy, sensitivity and specificity of a single bolus injection of 1.0 M Gadobutrol compared to 0.5 M Gd-DTPA at a dose of 0.1 mmol Gd/kg BW. The sequence protocol included dynamic-3D, static conventional and fat saturated 2D T1-weighted imaging. MR datasets were evaluated by 3 independent radiologists in a blinded reading setting. Additional analysis was performed by an independent truth panel in consensus reading of one radiologist and one hepatologist to verify the overall diagnosis by mapping the individual lesions.

A total of 497 out of 572 patients were eligible for final efficacy analysis. Non-inferiority of Gadobutrol-enhanced MRI was demonstrated on the basis of diagnostic accuracy rate, i.e. correct identification of at least one malignant lesion or exclusion of malignant disease on a per patient-level, of the different contrast media for combined MRI. For the clinical study a confidence interval of [-0.098, 0.021] as well as for the average reader of the blinded evaluation [-0.096, 0.014] [95% confidence interval] compared to the predefined standard of truth was calculated. Concerning the increase in diagnostic accuracy there was a trend toward the high-molar solution. For both contrast agent groups very similar increases in sensitivity (>20%) and specificity (app.10%) were observed compared to precontrast MRI with maximum differences 4%.

Non-inferiority of the high-molar MRI contrast agent Gadobutrol versus the standard contrast was documented regarding diagnostic accuracy in patients with liver tumors. Concerning the medium increase there was a trend toward the high-molar solution.

1.0 M Gadobutrol-enhanced MRI is non-inferior to 0.5 Gd-DTPA enhanced MRI in terms of diagnostic accuracy, sensitivity and specificity in the diagnosis of focal liver lesions.

Hammerstingl, R, Tombach, B, MRI of Focal Liver Lesions: A Multicenter, Randomized Trial in 572 Patients Using 1.0 Molar Gadobutrol and 0.5 Molar Gd-DTPA.  Radiological Society of North America 2007 Scientific Assembly and Annual Meeting, November 25 - November 30, 2007 ,Chicago IL. http://archive.rsna.org/2007/5013762.html